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Venezuela's leader visits, vows to invest in Benin Topix
- Sunday, August 13, 2006 Venezuela President Hugo Chavez wrapped up a two-week world tour and headed home after a brief visit to the tiny West African nation of Benin, where he pledged to invest in one of the world's poorest
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Grants Target Safety and Health Outreach in Developing Countries Topix
- Sunday, August 13, 2006 OEHS organizations in Venezuela, China, the Republic of Benin and Serbia and Montenegro are the recipients of the 2005 Worldwide Outreach Program grants from the Foundation for Occupational Health and Safety ,
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Benin, Venezuela advocate UN reform Topix
- Sunday, August 13, 2006 Presidents Yayi Boni Yayi of Benin and Hugo Chavez of Venezuela on Wednesday renewed calls for reforms that would reflect "more democracy" within the United Nations
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Full Issue in PDF Format FDAnews
- Sunday, August 13, 2006 View the entire issue in PDF
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Adjustments to CMS Final Rule Brighten Prospects for Device Firms, Experts Say FDAnews
- Sunday, August 13, 2006 The device industry, which feared a Centers for Medicare & Medicaid Services (CMS) proposal to cut reimbursement rates under Medicare’s inpatient prospective payment system (IPPS), can breathe a sigh of
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Regulators, Lawmakers Seek More Oversight of Genetic Test Sales FDAnews
- Sunday, August 13, 2006 Genetic test makers marketing their products for direct-to-consumer sale can expect to find themselves under a regulatory microscope after a government report found some manufacturers are testing the limits of advertising
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Clearer Interaction Needed Between Doctors, Firms on Heart Devices FDAnews
- Sunday, August 13, 2006 There is growing consensus that doctors need to work more closely with heart device manufacturers to establish guidelines for managing patients implanted with devices at risk for
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FDA Issues Q&A Guidance on HDE Regulation FDAnews
- Sunday, August 13, 2006 The FDA July 25 posted an updated guidance answering common questions about humanitarian use devices (HUDs) and applications for humanitarian device exemptions
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Device, Drug Industry Excluded From Anti-Kickback Safe Harbor FDAnews
- Sunday, August 13, 2006 HHS is excluding device and drugmakers from a new protection from the anti-kickback statute designed to promote adoption of electronic health records, arguing that these sectors cannot be trusted to abide by the
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Cardiac Science Receives Warning Letter for AEDs FDAnews
- Sunday, August 13, 2006 Cardiac Science, Bothel, Wash., received an FDA warning letter saying its automated external defibrillators (AEDs) are adulterated because of nonconformity with current good manufacturing practice
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Gurney Maker Says User Error Led to FDA Warning Letter FDAnews
- Sunday, August 13, 2006 The FDA warned the maker of a shower gurney that it was in violation of the agency’s reporting requirements after an incident in which a nursing home resident fell out of the gurney and was
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Briefs FDAnews
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Device Recalls FDAnews
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FDA: SUBSTITUTE SALIVA IS A REGULATED DEVICE, NOT COSMETIC FDAnews
- Sunday, August 13, 2006 In a July 10 warning letter, the FDA told the maker of a dry mouth reliever that its product is considered a saliva substitute, and therefore should be regulated as a medical
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FDA DEVELOPING TEST TO SCREEN FOR HOAX BIOTERROR AGENTS FDAnews
- Sunday, August 13, 2006 Researchers at the FDA's National Center for Toxicological Research are developing a new way to screen for and identify bioterror agents and other substances used in hoax incidents, the agency announced Aug.
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SENATE BILL TO DELAY DRA IMAGING CUTS GETS SUPPORT FROM RADIOLOGY GROUP FDAnews
- Sunday, August 13, 2006 The American College of Radiology (ACR) said Aug. 4 it strongly supports S. 3795, the Access to Medicare Imaging Act, which calls for a two-year moratorium on medical imaging reimbursement cuts included in the Deficit Reduction Act of 2005
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FDA ISSUES GUIDANCE ON FISCAL 2007 SMALL BUSINESS QUALIFICATION AND CERTIFICATION UNDER MDUFMA FDAnews
- Sunday, August 13, 2006 The FDA Aug. 3 posted a guidance issued Aug. 1 on small business qualification and certification under the Medical Device User Fee and Modernization Act
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THERAGENICS ACQUIRES DISPOSABLE MEDICAL DEVICE COMPANY FDAnews
- Sunday, August 13, 2006 Medical device company Theragenics Corp. has bought Galt Medical Corp. for $31.9 million to diversify its medical device and surgical
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TOMOTHERAPY RADIATION TREATMENTS BEGIN IN GERMANY FDAnews
- Sunday, August 13, 2006 TomoTherapy Incorporated announced that the University Clinic Heidelberg became the first German institution to treat cancer patients with the TomoTherapy(R) Hi-Art
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KOREA ON TRACK TO BECOME BIOTECHNOLOGY LEADER FDAnews
- Sunday, August 13, 2006 Fourteen years since the launch of the national research and development program in 1982, Korea still has a long way to go in achieving its ambitions of becoming a biotechnological world
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